Surgical tilt anvil assembly

ABSTRACT

An anvil and anvil delivery system is provided which includes a head assembly and a center rod defining a longitudinal axis. The head assembly defines a transverse axis and is pivotally secured to the rod and movable from an operative position wherein the transverse axis is substantially perpendicular to the longitudinal axis and a tilted position wherein the transverse axis defines an acute angle with respect to the longitudinal axis. A flexible tube is secured to the center rod which includes gradations along the length of the tube. The gradations are positioned to provide an indication of a length of the tube remaining in a patient during removal of the tube from the patient. An adapter is secured to one end of the flexible tube and to the center rod. The adapter is configured to secure the anvil assembly to the flexible tube.

CROSS REFERENCE TO RELATED APPLICATION

This present application is a continuation of application Ser. No.13/343,082, filed Jan. 4, 2012 which is a continuation of applicationSer. No. 12/512,342, filed on Jul. 30, 2009, now U.S. Pat. No.8,109,426, which claims the benefit of and priority to U.S. ProvisionalApplication Ser. No. 61/088,055 filed on Aug. 12, 2008, the entirecontents of each of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to an anvil assembly which issuitable for use with a circular anastomosis stapler. More specifically,the present disclosure relates to an anvil assembly having a tiltablehead which is suitable for use with a circular anastomosis stapler.

2. Background of Related Art

Circular anastomosis staplers which include an anvil assembly having atiltable anvil head are known in the art. U.S. Pat. No. 6,053,390discloses an anvil assembly having an anvil head that is tilted. Alinkage system for tilting the anvil assembly of a surgical stapler froma tilted to a non-tilted position during approximation and back to atilted position upon return of the anvil to a spaced position isdisclosed in U.S. Pat. No. 6,957,758. Other anvil assemblies which pivotfrom a tilted position to an operative position upon approximation ofthe anvil assembly and then return to the tilted position upon firing ofthe stapler are also known and are described in U.S. Pat. Nos. 7,168,604and 7,431,191. Another tilt anvil assembly is disclosed in U.S. PatentPublication 2008-0230581. Although the ability of the anvil head to bedelivered in the tilted reduced profile position and tilt once the anvilis attached to an instrument and subsequently approximated to anoperative position for firing of the staples has advantages, it would bedesirable provide a tilted anvil of simplified design and increasedcontrollability.

SUMMARY

A surgical tilt anvil assembly is provided. The tilt anvil assemblyincludes in one aspect a rod and a head assembly including an anvilplate having staple deforming pockets. The head assembly is pivotallysecured to the rod and pivotal in relation to the rod between a firsttilted position, a non-tilted operative position and a second differenttilted position, wherein the head assembly passes from the first tiltedposition, through the non-tilted position to the second tilted position.

The head assembly can include a backup member movable about a post froma first position in which the backup member is positioned to preventpivotal movement of the head assembly from the non-tilted position tothe second tilted position, to a second position in which the backupmember is positioned to permit pivotal movement of the head assembly inrelation to the rod from the non-tilted position to the second tiltedposition.

The head assembly of the tilt anvil assembly may further include apivotal cam latch member positioned to engage the backup member toprevent movement of the backup member from the second position to thefirst position. The head assembly may be pivotally secured to the rodabout a pivot member, and a pivotal latch member may be pivotallymounted about the pivot member. The latch member may be positioned toengage an inner periphery of the backup member when the backup member isin its first position. The latch member may include a curved surfacewhich is configured to eliminate any gap between the latch member andthe backup member during movement of the head assembly from the firstposition to the second position.

The tilt anvil assembly may further include a plunger which is urged bya biasing member into engagement with the cam latch member to urge thecam latch member to its pivoted position. The tilt anvil assembly mayfurther include a retainer member positioned in the head assembly toprevent movement of the backup member from the first position to thesecond position until a predetermined force has been applied to thebackup member. The retainer member may include a deformable member whichis positioned in the head assembly between the housing and the backupmember. The housing and the post may define an annular recess, and theretainer member can be positioned in the annular recess. The retainermember may include an annular body positioned about the post and aplurality of deformable tabs extending therefrom.

The backup member can be positioned to abut the retainer member suchthat upon movement of the backup member from its first position to itssecond position, the deformable tabs are deformed. The backup member mayinclude a cutting ring and a backup plate, and the cutting ring can besecured to a proximal face of the backup plate. The backup plate mayinclude at least one finger positioned to engage a surface of the rodwhen the backup member is in its first position to prevent pivotalmovement of the head assembly in relation to the rod. The cutting ringmay be formed from a softer material than the backup plate. The rod maydefine a longitudinal axis and a pivot axis of the head assembly canintersect the longitudinal axis of the center rod.

In a preferred embodiment, the head assembly is maintained in a firsttilted position by a tensioning member connected to the head assembly.In a preferred embodiment, the tensioning member is a suture received inan opening in the head assembly. A second suture can be provided in asecond opening in the head assembly extending in a direction oppositethe first suture for retrieval of the anvil assembly.

In another aspect of the disclosure a surgical tilt anvil assembly isprovided including a rod and an anvil head assembly pivotally secured tothe rod and pivotal in relation to the rod in a first direction from afirst tilted position for insertion to an operative position, andfurther pivotal in relation to the rod in the first direction from theoperative position to a second tilted position for removal.

The head assembly in a preferred embodiment moves through an arc ofabout 140 degrees from the first tilted position to the second tiltedposition. The head assembly may further include a pivotal latch memberpositioned to prevent movement of a backup member of the head assemblyfrom a second position to an initial position. A plunger in a preferredembodiment moves the head assembly from the first tilted position to theoperative position and from the operative position to the second tiltedposition. In a preferred embodiment, a suture maintains the headassembly in the first tilted position.

In another aspect of the present disclosure, a surgical anvil assemblyis provided comprising a rod and a head assembly including a housing, acam member and a backup member. The head assembly is pivotally securedto the rod and pivotal in relation to the rod in a first direction froma first tilted position for insertion to an operative position, andfurther pivotal in relation to the rod from the operative position to asecond tilted position different from the first tilted position. The cammember prevents proximal movement of the backup member after the backupmember is advanced distally. The anvil assembly can further include aplunger spring biased into engagement with the cam member.

In another aspect of the present disclosure a surgical anvil deliverysystem is provided comprising an anvil assembly including a rod and ahead assembly, a flexible tube and a tensioning member. The headassembly is pivotally secured to the rod and movable from a first tiltedposition to a non-tilted operative position. The anvil assembly isconnected to the flexible tube and the tensioning member is connected tothe head assembly and maintains the head assembly in the first tiltedposition such that release of the tensioning member returns the headassembly to the non-tilted position. In a preferred embodiment, thetensioning member is a suture extending through a hole in the headassembly and into an opening in the flexible tube. The system mayfurther include a second suture connected to the head assembly andextending in a direction different than the first suture.

In a preferred embodiment, the head assembly is further pivotable to asecond tilted position after positioning in the operative non-tiltedposition, wherein the second tilted position is different than the firsttilted position. The anvil assembly may further include a rotatable cammember and a plunger spring biased into contact with the cam member,wherein the cam member is rotatable and the plunger is movable distallyto move the head assembly from the first tilted position to theoperative position and further movable to move the head assembly fromthe operative position to a second different tilted. An adapter can beprovided to connect the anvil assembly to the flexible tube.

In another aspect, the present disclosure provides a method for pivotingan anvil head assembly of a surgical anvil assembly comprising the stepsof:

providing an anvil assembly including a rod and a head assemblypivotally secured to the rod, the head assembly movable from a firsttilted position to a non-tilted operative position, the anvil assemblyconnected to a flexible tube and retained in a first tilted position bya tensioning member;

inserting the anvil assembly into a patient with the anvil held in thefirst tilted position by the tensioning member; and

severing the tensioning member to cause the head assembly to move in afirst direction to return to the non-tilted operative position.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed tilt anvil assembly aredisclosed herein with reference to the drawings wherein:

FIG. 1 is a perspective view of a surgical stapling device including anembodiment of an anvil assembly according to the present disclosure;

FIG. 2 is a first perspective side view of the anvil assembly of FIG. 1in the non-tilted position;

FIG. 3 is a second perspective side view of the anvil assembly shown inFIGS. 1 and 2;

FIG. 4 is an exploded side view of the anvil assembly of FIGS. 1-3;

FIG. 5 is an end view of the anvil assembly of FIGS. 1-3;

FIG. 6 is a cross-sectional side view of a distal end of the tilt anvilassembly of FIGS. 1-4 taken along line 6-6 of FIG. 5 and showing thehead assembly in the non-tilted operative position;

FIG. 7 is a cross-sectional side view of a distal end of the anvilassembly of FIGS. 1-6 taken along line 7-7 of FIG. 5 and showing thehead assembly in the non-tilted operative position;

FIG. 8 is an enlarged side view of the cam latch member of the anvilassembly of FIGS. 1-4;

FIG. 9 is a top view of the anvil assembly of FIGS. 1-4 supported on ananvil delivery system;

FIG. 10 is an enlarged exploded view of the anvil delivery system ofFIG. 9;

FIG. 11 an enlarged top view of the anvil delivery system of FIGS. 9 and10, including the anvil assembly of FIGS. 1-4 shown in the first tiltedposition tensioned by the suture;

FIG. 12 is a cross-sectional side view of the anvil assembly and anvildelivery system of FIG. 11 taken along lines 12-12 of FIG. 11;

FIG. 13 is a cross sectional side view (showing the area of detail ofFIG. 12) of the anvil assembly of FIGS. 1-4, in a pre-fired tiltedposition supported on the anvil delivery system of FIG. 9;

FIG. 14 is an enlarged view of portion 14 of FIG. 13;

FIG. 15 is an illustration of the surgical stapling instrument of FIG. 1and the anvil delivery system of FIG. 9 with connected anvil assemblybeing inserted trans-orally into a patient;

FIG. 16 is an enlarged side view of the distal head portion of thesurgical stapling device of FIGS. 1 and 15;

FIG. 17 is an enlarged side view of the distal head portion of thesurgical stapling device of FIGS. 1 and 15, showing the anvil assemblyof FIGS. 1-4 received thereon.

FIG. 18 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. 1, including theconnected anvil assembly of FIGS. 1-4 shown in an approximated pre-firednon-tilted operative position;

FIG. 19 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. 1, including theconnected anvil assembly of FIGS. 1-4 shown in a post-fired non-tiltedoperative position;

FIG. 20 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-4 in the post-fired non-tilted operativeposition corresponding to the position of FIG. 19;

FIG. 21 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-4 in a post-fired second tilted position;

FIG. 22 is a cross-sectional side view of the anvil assembly of FIGS.1-4 in a post-fired second tilted position (corresponding to theposition of FIG. 21) shown supported on an anvil retainer of thesurgical stapling device of FIG. 1;

FIG. 22A is another cross-sectional side view of the anvil assembly ofFIGS. 1-4 corresponding to the anvil assembly position of FIG. 22;

FIG. 23 is an enlarged view showing the designated area of detail ofFIG. 22A; and

FIG. 24 is a side view of the anvil assembly of FIG. 22 supported on theanvil retainer of the surgical stapling device of FIG. 1.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed anvil assembly will now bedescribed in detail with reference to the drawings in which likereference numerals designate identical or corresponding elements in eachof the several views. Throughout this description, the term “proximal”will refer to the portion of the instrument closer to the operator andthe term “distal” will refer to the portion of the instrument furtherfrom the operator.

FIG. 1 illustrates an embodiment of a surgical stapling deviceconfigured for use with a tilt anvil assembly according to the presentdisclosure. Briefly, surgical stapling device 10 includes a proximalhandle assembly 12, an elongated central body portion 14 including acurved elongated outer tube 14 a, and a distal head portion 16.Alternately, in some surgical procedures, e.g., the treatment ofhemorrhoids, it is desirable to have a substantially straight,shortened, central body portion. The length, shape and/or the diameterof body portion 14 and distal head portion 16 may also be varied to suita particular surgical procedure.

With reference still to FIG. 1, handle assembly 12 includes a stationaryhandle 18, a firing trigger 20, a rotatable approximation knob 22 and anindicator 24. A pivotally mounted trigger lock 26 is fastened to handleassembly 12 and is manually positioned to prevent inadvertent firing ofstapling device 10. Indicator 24 is positioned on the stationary handle18 and includes indicia, e.g., color coding, alpha-numeric labeling,etc., to identify to a surgeon whether the device is approximated and isready to be fired. Head portion 16 includes an anvil assembly 110 and ashell assembly 31. A more detailed discussion of surgical stapler 10 isdisclosed in U.S. Pat. No. 7,364,060 and 7,303,106, the contents ofwhich are incorporated herein by reference in its entirety.

Referring now to FIGS. 2-7, an embodiment of the anvil assembly of thepresent disclosure is shown generally as reference numeral 110. Anvilassembly 110 is shown in a non-tilted or operative position wherein thestaple deforming pockets 130 face the staple slots of the instrument.Anvil assembly 110 includes a head assembly 112 and a center rodassembly 114. Head assembly 112 includes a post 116, a housing 118, abackup member or plate 120, a cutting ring 122, a cutting ring cover123, an anvil plate 124, a spacer or washer 125, a cam latch member 126,and a retainer member 127. Post 116 is monolithically formed with andcentrally positioned within housing 118. Alternately, housing 118 andpost 116 may be formed separately and fastened together using a knownfastening technique, e.g., welding.

As will be discussed in further detail below, housing 118 includesopenings 119 a, 119 b sized and dimensioned to receive one or moresutures “S”. During use, a first suture “S₁” (FIG. 11) is insertedthrough openings 119 a and is used to retain head assembly 112 in aretracted or first tilted position (FIGS. 11 and 12) during insertion ofanvil assembly 110 within a patient. That is, suture “S₁” operates as atensioning member to maintain the head assembly in the first tiltedposition. A second suture “S₂” is inserted through openings 119 b and isconfigured to permit retrieval of tilt anvil assembly 110 from within apatient if desired. During trans-oral insertion of anvil assembly 110,suture “S₂” extends from the mouth of patient, permitting the anvilassembly 110 to be retrieved trans-orally. As shown, second suture “S₂”extends in a direction opposite the direction of suture “S₁”.

With reference still to FIGS. 2-7, anvil plate 124 is supported in anouter annular recess 128 of housing 118 and includes a plurality ofstaple deforming pockets 130 for receiving and deforming staples. Atleast one tab 124 a extends radially outwardly from anvil plate 124 andis received within a cutout 132 formed in an outer rim of housing 118.Tab 124 a and cutout 132 function to align or properly position anvilplate 124 within annular recess 128 of housing 118.

With particular reference to FIGS. 4, 6 and 7, head assembly 112 will bedescribed in detail. Backup plate 120 includes a central opening 134which is positioned about post 116 within an inner annular recess 136 ofhousing 118 between post 116 and outer annular recess 128. Backup plate120 includes a raised platform 120 a. Cutting ring 122 includes anopening 122 a having a configuration substantially the same as platform120 a. Although platform 120 a is illustrated as having a circularshape, other configurations are envisioned, e.g., square, rectangular,triangular, etc. In one embodiment, cutting ring 122 is formed frompolyethylene and is fixedly secured to backup plate 120 using, forexample, an adhesive, to form a backup plate/cutting ring assembly.Backup plate 120 is formed from a hard material, e.g., a metal.Alternately other materials of construction may be used to constructbackup plate 120 and cutting ring 122. Further, backup plate 120 andcutting ring 122, in the alternative, can be formed as a single orunitary structure.

Still referring to FIGS. 6 and 7, a cutting ring cover 123 is secured toan outwardly facing or proximal surface of cutting ring 122 using, forexample, an adhesive. In one embodiment, cutting ring cover 123 isformed from a material or materials, which have a hardness greater thanthat of the cutting ring, e.g., mylar. In one embodiment, cutting ringcover 123 includes two layers of mylar (not shown) which are joinedtogether using an adhesive and a polypropylene coating. Alternately,cutting ring 122 need not have a cover. Cutting ring 122 and backupplate 120 are slidably mounted about post 116. Backup plate 120 includesa pair of inwardly extending fingers 138 which will be described infurther detail below.

With reference still to FIGS. 4, 6 and 7, retainer member 127 ispositioned in inner annular recess 136 between backup plate 120 and aback wall 118 a of housing 118. In one embodiment, retainer member 127is annular and includes a plurality of deformable tabs 127 a whichengage a rear surface of backup plate 120. Retainer member 127 preventsbackup plate 120 and cutting ring 122 from moving or being pushed intoinner annular recess 136 of housing 118 until a predetermined forcesufficient to deform tabs 127 a has been applied to the backupplate/cutting ring assembly. The predetermined force can be close to butis less than the force applied by an annular cutting blade of a surgicalstapling device when it engages, for example, the cutting ring of anvilassembly 110. In one embodiment by way of example, the predeterminedforce is between about ten pounds and about ninety pounds and can beabout thirty (30) pounds. When the predetermined force is reached, e.g.,during cutting of tissue, backup plate 120 is urged into inner annularrecess 136 and compresses retainer member 127. It is envisioned thatother crushable, deformable, collapsible or movement restricting membersmay be used to retain the backup plate/cutting ring assembly in a fixedposition until a predetermined force has been applied to the backupplate/cutting ring assembly.

As illustrated in FIG. 4, anvil center rod assembly 114 includes acenter rod 152, a plunger 154 and plunger spring 156. A first end ofcenter rod 152 includes a pair of arms 159 which define a cavity 159 a.Each arm 159 has a transverse throughbore 158 which is aligned with acentral longitudinal axis of center rod 152. Alternately, throughbores158 can be offset from the longitudinal axis of center rod 152. Post 116of anvil head assembly 112 is dimensioned to be positioned within cavity159 a and also includes a transverse throughbore (not shown). A pivotmember 162 pivotally secures post 116 to center rod 152 via thethroughbores such that anvil head assembly 112 may be pivotally mountedto anvil center rod assembly 114.

Turning briefly to FIG. 8, cam latch member 126 includes a body 126 ahaving a throughbore 126 b. Throughbore 126 b is dimensioned to receivepivot member 162 such that cam latch member 126 is pivotally mountedwithin transverse slot 172 (FIG. 3) of post 116 about pivot member 162.Referring now to FIGS. 3, 6 and 7, cam latch member 126 includes a firstbody portion 126 c which extends partially from slot 172 of post 116 andis positioned to be engaged by a finger 166 of plunger 154. First bodyportion 126 c is configured such that the distance between the surfaceof first body portion 126 c and throughbore 126 b increase in aclockwise direction about cam latch member 126. In this manner, plunger154 is able to move forward as cam latch member 126 rotates in aclockwise direction. Additionally, this configuration of first bodyportion 126 c permits plunger 154 to be retracted as cam latch memberrotates in a counter-clockwise direction. Cam latch member 126 alsoincludes an edge 126 f, including a tab 126 g. A leading portion of edge126 f is configured to be urged into engagement with an inner periphery120 b of backup plate 120 by an engagement finger 166 of plunger 154when anvil head 112 is in its non-tilted or operative position. Tab 126g is configured to engage backwall 118 a of housing 118 to prevent camlatch member 126 from rotating counter-clockwise relative to housing118.

With reference to FIG. 6, plunger 154 is slidably positioned in a bore164 formed in the first end of center rod 152. Plunger 154 includes anengagement finger 166 which is offset from the pivot axis of anvil headassembly 112 and biased into engagement with edge 126 c of cam latch126. Engagement of finger 166 with edge 126 c of cam latch 126 presses aleading portion of edge 126 f against an inner periphery of back plate120 to urge anvil head assembly 112 to an operative or non-tiltedposition on center rod 152. In this non-tilted position, finger 166remains spaced proximally from post 116 of anvil assembly 110.

Turning to FIG. 7, in the pre-fired operative position of head assembly112, i.e. when head assembly 112 has been pivoted to its non-tiltedposition, fingers 138 formed on backup plate 120 engage protrusions 152b adjacent top surface 152 a of center rod 152 to prevent head assembly112 from pivoting about pivot member 162.

Anvil head assembly 112 may be tilted a degrees (FIG. 13) relative toanvil center rod assembly 114 to the pre-fired first tilted position bythe suture “S₁” as described below for insertion. In one embodiment,anvil head assembly 112 is tilted less than ninety degrees andpreferably about seventy degrees (70°) in its pre-fired tilted position;however it should be understood that tilting head assembly 112 to otherdegrees is also contemplated. Titling of anvil head assembly 112relative to anvil center rod assembly 114 by the suture S1 causes camlatch member 126 positioned within the inner periphery of the backupplate 120 to rotate, causing body portion 126 c of cam latch member 126to engage finger 166 of plunger 154. As cam latch assembly 126 rotatescounterclockwise (as viewed in FIG. 14) with the tilting of anvil headassembly 112, plunger 154 is retracted within bore 164 of anvil centerrod assembly 114, thereby compressing spring 156. In this manner, finger166 of plunger 154 is distally biased against body portion 126 c of camlatch member 126.

With reference to FIGS. 3 and 4, a second end of center rod 152 includesa bore 180 defined by a plurality of flexible arms 182. Flexible arms182 each include an opening 182 a dimensioned to receive a projectionformed on or connected to a shell assembly 31 (FIG. 18). Alternatively,openings 182 a may be configured to receive a suture for permittingretrieval of anvil assembly 110. The proximal ends of each of theflexible arms 182 include an internal shoulder 184 dimensioned toreleasably engage shell assembly 31 of surgical stapling device 10 tosecure anvil assembly 110 to the surgical stapling device. A pluralityof splines 186 are formed about center rod 152. Splines 186 function toalign anvil assembly 110 with the staple holding portion of a surgicalstapling device. Center rod 152 also includes an annular recessedportion 190 to facilitate grasping of anvil assembly 110 by a surgeonwith a grasper. Recessed portion 190 may include a roughened or knurledsurface or an overmold to facilitate grasping of anvil assembly 110.

With reference now to FIGS. 9-12, a system for delivering anvil assembly110 within a patient is shown generally as anvil delivery system 50.Anvil delivery system 50 includes a flexible tube 52 and an adapter 62.Flexible tube 52 includes an open end 52 a. Adapter 62 and anvilassembly 110 are supported on open end 52 a of flexible tube 52. Openend 52 a of flexible tube 52 includes a throughbore 53 extendingtherethrough configured to receive a locking pin 54. Open end 52 afurther includes an opening 55, used for alignment of the printing onthe tube 50 during manufacture. Closed end 52 b of flexible tube 52 isconfigured for trans-oral insertion in a patient. Flexible tube 52 mayinclude markings or other gradations 56 along the length thereof toindicate to a surgeon how much of flexible tube 52 has been receivedwithin the patient during insertion and/or to indicate the length offlexible tube 52 remaining in the patient during removal.

With particular reference to FIG. 10, adapter 62 includes a first end 62a configured to be received within open end 52 a of flexible tube 52 anda second end 62 b configured to be received within bore 180 formed incenter rod 152 of anvil assembly 110. First end 62 a includes a seriesof annular rings 64 configured to frictionally retain first end 62 a ofadapter 62 within open end 52 a of flexible tube 52. Second end 62 b ofadapter 62 includes a longitudinal guide member 66 configured to bereceived between flexible arms 182 formed in center rod 152 of anvilassembly 110. In addition, second end 62 b of adapter 62 is sized toallow center rod 152 of anvil assembly 110 to freely slide into and offsecond end 62 b of adapter 62. Adapter 62 further includes a firstthroughbore 70 formed in a central hub portion 62 c as well as secondand third throughbores 72, 74 formed in first end 62 a. Throughbore 72is configured to align with throughbore 53 formed in open end 52 a offlexible tube 52 and is sized to receive locking pin 54. Bore 74 isconfigured to receive both ends of the suture S1. Bore 70 can alsoreceive the suture ends to enhance retention.

With particular reference now to FIGS. 10-14, anvil assembly 110 issupported on anvil delivery system 50. Securing anvil assembly 110 toanvil delivery system 50 requires that suture “S₁” is thread throughopenings 119 a (shown also in FIG. 2) formed on anvil head 112 such thatfirst and second ends of suture “S₁” are positioned on different sidesof center rod 152. Second end 62 b of adapter 62 is positioned withinthroughbore 180 of center rod 152 such that longitudinal guide 66 isreceived between two of arm members 182. Each of the first and secondends of suture “S₁” is preferably inserted through bore 74 formed inadapter 64 and through open end 52 a of flexible member 52. Anvil head112 is then rotated to a first tilted position as first and second endsof suture “S₁” are pulled through opening 74, applying tension on theanvil head forcing it to pivot counterclockwise as viewed in theorientation of FIG. 13. Such pivoting forces plunger 154 proximally asdescribed above.

First end 62 a of adapter 62 is inserted into open end 52 a of flexiblemember 52. The frictional contact between annular rings 64 of first end62 a of adapter 62 and an inner surface of flexible tube 52 securesadapter 62 to flexible tube 52 and prevents suture “S₁” from looseningas it is clinched between the outer wall of the adapter 62 and innerwall of flexible tube 52. It is envisioned that more than one suture maybe used to secure anvil head assembly 112 in a pre-fired tiltedposition. It is also envisioned that the suture Si need not be passedthrough bore 74 but instead is just clamped between the adapter 62 andthe inner wall of the flexible tube 52.

With reference now to FIG. 15, a method for delivering anvil assembly110 to a surgical site within a patient will be described. In onepreferred method, anvil assembly 110 is provided in the first tiltedposition supported on anvil delivery system 50 and ready for delivery.Alternatively, a clinician secures anvil assembly 110 to anvil deliverysystem 50 as discussed above. With anvil assembly 110 secured toflexible tube 52, the surgeon inserts closed end 52 b of flexible tube52 in the patient's mouth “M” and moves closed end 52 b along withflexible tube 52 down through esophagus “E” to a surgical site, i.e.,the stomach “St”.

After insertion, the surgeon then makes a first incision “I₁” at thesurgical site (stomach “St” as shown) to create an inner access toclosed end 52 b of flexible tube 52 and then pulls open end 52 b offlexible tube 52 through first incision “I₁”. In some procedures it maybe beneficial to pull flexible tube 52 through incision “I₁” untilcenter rod 152 of anvil assembly 110 advances through first incision“I₁”. When anvil assembly 110 is properly positioned at the surgicalsite, the surgeon releases anvil delivery system 50 from anvil assembly110 by cutting suture “S₁” and separating anvil assembly 110 from secondend 62 b of adapter 62. Flexible tube 52 (with fitting 62) may then bepulled from the body through first incision “I₁”.

Severing of suture “S₁” permits plunger 154 to extend from within bore164, thereby causing finger 166 to engage body portion 126 c of camlatch member 126. Rotation of cam latch member 126 (clockwise as viewedin the orientation of FIG. 14) causes edge 126 f of latch member 126,engaged with the inner periphery of backup plate 120, to urge anvil headassembly 112 to return to a non-tilted operative position (e.g. theposition of FIG. 6). Additionally, the distal end of stapling device 10may be configured to engage finger 166 of plunger 154 as anvil assembly110 is attached to surgical stapling device 10. In this manner, thedistal end of surgical stapling device 10 urges plunger 154 distally,thereby ensuring the rotation of cam latch 126 and anvil head assembly112 to a non-tilted position.

With particular reference to FIG. 15, in one method, a second incision“I₂” is then formed at the surgical site such that distal head portion16 of surgical stapling device 10 may be received therethrough.Alternatively, distal head portion 16 of surgical stapling device 10 maybe received through first incision “I₁” once anvil delivery system 50has been removed therefrom.

Turning briefly to FIGS. 16 and 17, anvil assembly 110 is operablyreceived on an anvil retainer 32 extending from shell assembly 31 formedon a distal end of surgical stapling device 10. Once anvil assembly 110is received on surgical stapling device 10, surgical stapling device 10operates in the manner discussed in U.S. Pat. No. 7,364,060, previouslyincorporated herein in its entirety by reference. Note thatalternatively, suture S1 can be severed after the distal head portion 16of the stapling device 10 receives the anvil assembly 110. Afterattachment, the rotation knob 22 is rotated to approximate the anvilassembly 110 and distal head portion 16 to clamp tissue therebetween,and then the firing trigger is actuated to fires the staples asdisclosed in U.S. Pat. No. 7,364,060.

The operation of anvil assembly 110 will now be described with referenceto FIGS. 18-23. When anvil assembly 110 is in its pre-fired non-tiltedposition (e.g. FIG. 18), backup plate 120 is spaced from backwall 118 aof housing 118 by retainer 127 and protrusions 152 b of center rod 152engage fingers 138 of backup plate 120 (also shown in FIGS. 6 and 7) toprevent tilting of anvil head assembly 112 about pivot member 162.Finger 166 of plunger 154 is urged by spring 156 into engagement withbody portion 126 c of cam latch member 126 to urge cam latch member 126in a clockwise direction (as viewed in FIG. 18), about pivot member 162such that edge 126 f of cam latch member 126 engages inner periphery 120b of backup member 120.

The firing of surgical stapling device 10 causes a knife blade 33thereof to engage cutting ring 122 to move cutting ring 122 and backupplate 120 into annular recess 136 of housing 118 of anvil head assembly112. Arrows “W” in FIG. 19 indicate how cutting ring 122 and backupplate 120 move as a result of the firing of surgical stapling device 10.When such movement occurs, deformable tabs 127 a of retainer 127(labeled in FIGS. 6 and 7) are deformed against backwall 118 a ofhousing 118 and fingers 138 of backup member 120 move away fromprotrusions 152 b of center rod 152. Further, inner periphery 120 b ofbackup plate 120 moves past edge 126 f of cam latch member 126 such thatcam latch member 126 is urged to pivot about pivot member 162 (clockwiseas viewed in the orientation of FIG. 21) in the direction indicated byarrow “X” in FIGS. 21 and 22 by plunger 154 (spring biased distally) toa position in which body portion 126 e of cam latch 126 is positioned infront of and engages backup plate 120. Engagement of plunger 154 withcam latch member 126 urges cam member 126 to further rotate clockwisewhich due to its configuration enables spring biased plunger 154 to movefurther distally so angled surface 167 of plunger 154 contacts thesurface of post 116 of anvil head assembly 112 to move the anvil headassembly 118 to a second tilted position (FIGS. 22A and 23). It is notedthat anvil head assembly 112 will not immediately tilt to its secondtilted position upon firing of surgical stapling device 10 because, uponfiring, anvil head assembly 112 is in an approximated position, i.e.,the anvil head assembly 112 is in close alignment with shell assembly 31of stapling device 10, and, therefore, does not provide room for headassembly 112 to pivot. As such, the anvil head assembly 112 will onlybegin to tilt when anvil assembly 110 and shell assembly 31 of surgicalstapling device 10 are being unapproximated and there is a sufficientgap between the anvil assembly 110 and the distal head portion 16 of thestapling device 10.

As anvil head assembly 112 pivots towards its forward or second tiltedposition, finger 166 of plunger 154 maintains surface 126 e of cam latchmember 126 in contact with backup plate 120 to prevent backup plate 120from sticking to the knife blade as the knife blade is retracted. It isnoted that curved surface 126 e of cam latch member is configured toeliminate any gap and ensure contact between surface 126 e of cam latchmember 126 and backup plate 120 to hold backup plate 120 in place duringand after the knife blade is retracted such that the cutting ring andbackup plate assembly stay in their correct position during continuedtilting of anvil assembly 112. Anvil assembly 110 is configured suchthat anvil head assembly tilts to a forward or second tilted position βdegrees (FIG. 24) relative to center rod assembly 114. As can beappreciated, the anvil head assembly therefore pivots in a firstdirection from an initial (first) tilted position to an unfilledoperative position for application of staples. After firing of theinstrument, the anvil head pivots in the same direction to a secondtilted position. In one embodiment, anvil head assembly 112 is tiltedless than ninety degrees and preferably about seventy degrees (70°) toits second tilted position such that the total pivoting movement of theanvil from the retracted or first tilted position to the forward orsecond tilted position is about one-hundred and forty degrees (140°). Itshould however be noted that the tilting of anvil head assembly 112 toother degrees for the first and/or second tilted position is alsocontemplated.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the cutting ring and backupplate can be unitarily or integrally formed. Further, the anvil assemblyneed not have cutting ring cover. Therefore, the above descriptionshould not be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1-12. (canceled)
 13. An anvil and anvil delivery system comprising: ananvil assembly including a head assembly and a center rod defining alongitudinal axis, the head assembly defining a transverse axis andbeing pivotally secured to the center rod and movable from an operativeposition to a first tilted position; an adapter having a first endsecured to the center rod and a second end; a flexible tube having anopen end secured to the second end of the adapter; and a first suturesecured to the head assembly, the first suture being positioned intension to maintain the head assembly in the first tilted position,wherein the first suture is positioned in frictional contact between aninner surface of the flexible tube and the second end of the adapter toretain the first suture in tension.
 14. The anvil and anvil deliverysystem according to claim 13, wherein the head assembly further includesa post and a backup member, the backup member being movable about thepost from a first position in which the backup member is positioned toprevent pivotal movement of the head assembly from the operativeposition to a second tilted position, to a second position in which thebackup member is positioned to permit pivotal movement of the headassembly in relation to the center rod from the operative position tothe second tilted position.
 15. The anvil and anvil delivery systemaccording to claim 14, wherein the head assembly further includes apivotal cam member positioned to prevent movement of the backup memberfrom the second position to the first position.
 16. The anvil and anvildelivery system according to claim 13, wherein the head assembly ispivotally secured to the center rod about a pivot member, and a pivotalcam member is pivotally mounted about the pivot member.
 17. The anviland anvil delivery system according to claim 14, wherein a cam latchmember is configured to maintain engagement with the backup member whenthe head assembly moves from the operative position to the second tiltedposition such that movement of the backup member from the secondposition towards the first position is prevented.
 18. The anvil andanvil delivery system according to claim 17, wherein the cam latchmember is positioned to engage an inner periphery of the backup memberwhen the backup member is in the first position.
 19. The anvil and anvildelivery system according to claim 17, wherein the anvil assemblyfurther includes a plunger and a biasing member, the biasing memberurging the plunger into engagement with the latch member to urge the camlatch member to a pivoted position.
 20. The anvil and anvil deliverysystem according to claim 14, further including a retainer memberpositioned in the head assembly to prevent movement of the backup memberfrom the first position to the second position until a predeterminedforce has been applied to the backup member.
 21. The anvil and anvildelivery system according to claim 14, wherein in the first tiltedposition the head assembly is at an angle is less than 90 degrees withrespect to the operative position and in the second tilted position thehead is at an angle less than 90 degrees with respect to the operativeposition.
 22. The anvil and anvil delivery system according to claim 13,further including a second suture and a second opening in the headassembly positioned to receive the second suture, the second sutureextending in a direction opposite to a direction that the first sutureextends from the head assembly to facilitate retrieval of the anvilassembly.
 23. The anvil and anvil delivery system according to claim 14,wherein the first tilted position is different from the second tiltedposition.